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FDA-Device2026-02-11Class IIPROCESSING DEFECT

Vantive Prismaflex M100 dialyzer set recalled for deaeration chamber dislodgement risk

Vantive
OTHERNationwide distribution

Stop using Vantive Prismaflex M100 dialyzer sets

Vantive US Healthcare is recalling Prismaflex M100 dialyzer sets because the deaeration chamber may separate from the control unit during use. This affects units manufactured on or after lot 24F0077CA. The FDA has classified this as a Class II recall.

  • Stop using affected Prismaflex M100 sets (Product Code 106697) immediately
  • Check your dialyzer set lot number on the packaging—it should be listed on or after 24F0077CA
  • Contact Vantive US Healthcare or your dialysis provider for instructions on replacement or return
  • Do not discard the device; your provider may need it for records
Hazard

There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.

Sold states
US Nationwide distribution.
Affected count
230,596 units
Manufactured in
510 Lake Cook Rd, N/A, Deerfield, IL, United States
Products
PRIMSAFLEX M100 SET, Product Code 106697; Dialyzer, High Permeability With Or Without Sealed Dialysate System

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1227-2026

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